Manual Therapy on Oral Opening, Swallow Function and Upper Quarter Mobility on Head and Neck Cancer Survivors (MaTeO)

Universidad de La Frontera

Status: Enrolling

Conditions: Dysfunction; Trismus; Head and Neck Cancer

Treatments: Other: Motor control exercises; Other: Manual Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06148077

DIM23-0023

Details and patient eligibility

About

Trismus has been reported as the second most common comorbidity in survivors of head and neck cancer (HNC). It is mainly associated with post-radiotherapy subcutaneous fibrosis, muscular atrophy, damage to neurological structures in the neck, or a combination of all, affecting masticatory musculature. In addition to this, the loss of flexibility and strength in the shoulder has also been shown to be related to deficits in the function and quality of life of these patients.

The goal of this clinical trial is to determinate the effectiveness and safety of Manual Therapy (MT) on Oral Opening, Swallow Function, as well as the mobility of the upper quarter, the strength of cervical musculature, pain, functionality, and the perception of quality of life in head and neck cancer survivors.

Participants will be assigned randomly to the study groups: a) manual therapy program and control motor exercises and b) motor control exercises (usual care).

The assessment refers to a baseline form (at the beginning of the study), at 6 weeks and at 6 weeks of patient follow-up.

Full description

Manual therapy program consists of 3 sessions a week during 6 weeks, with a total of 18 appointments. Measurements are done before starting, after the last intervention and 6 weeks after finishing the treatment.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• individuals with HNC
• individuals over 18 years of age
• individuals who have undergone oncological surgery of the head and neck and/or radiotherapy
• having finished oncological medical treatment between 3 and 36 months before inclusion
• having a medical diagnosis of trismus and/or TMD and/or cervical or shoulder dysfunction
• Spanish native speakers

Exclusion criteria

• sequelae of previous stroke
• structural instability and/or osteoporosis of the cervical spine, spondylosis, cervical herniated discs
• active osteoradionecrosis or open wounds (fistulas, soft tissue necrosis) in the anatomical treatment area
• tracheostomized individuals
• metastasis or active cancer
• refuse to participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups

Manual Therapy

Experimental group

Description:

Manual Therapy-based intervention: the session will be performed with the patient in a supine position. If they cannot reach this position, it can be done with the patient sitting in a chair to receive the treatment. The selected maneuvers will focus on cervical, masticatory, and shoulder regions. Besides, intraoral maneuvers will be made using latex gloves, for masseter, medial, and lateral pterygoid muscles. Subsequently, motor control exercises will be performed

Treatment:

Other: Manual Therapy

Motor Control

Active Comparator group

Description:

Motor control (exercise): the session will focus on strengthening and stretching exercises for the cervical, masticatory, and shoulder muscles .

Treatment:

Other: Motor control exercises